Aachen, Germany, 28. September 2023 – PAION AG (ISIN DE000A3E5EG5; Frankfurt Stock Exchange, Prime Standard: PA8), a specialty pharmaceutical company with innovative compounds for use in outpatient and hospital sedation, anesthesia and critical care announces that Mundipharma, licensee of remimazolam (Japanese Trade name: Anerem®) for Japan, has informed PAION that it has submitted an application for an additional indication for remimazolam (Anerem® 50mg) for intravenous injection with the indication of “sedation during examination and procedures in gastrointestinal endoscopy'.

亚琛，德国，28岁。2023年9月-PAION AG（ISIN DE000A3E5EG5；法兰克福证券交易所，主要标准：PA8）是一家专业制药公司，拥有用于门诊和医院镇静，麻醉和重症监护的创新化合物，宣布remimazolam的被许可人Mundipharma（日本商品名：Anerem®）为日本，已经通知PAION，它已经提交了一份申请，要求瑞米唑仑（Anerem®50mg）用于静脉注射，并标明“胃肠道内窥镜检查和检查过程中的镇静”。

In addition, a new application was submitted for an additional dosage form of remimazolam (Anerem® 20 mg) for Intravenous Injection for the indications of “induction and maintenance of general anaesthesia” and “sedation during examination and procedures in gastrointestinal endoscopy”.Both applications are based on the results of domestic physician led clinical trials Phase II and III studies.

此外，提交了一份新的申请，用于静脉注射雷米佐仑（Anerem®20 mg）的额外剂型，用于“诱导和维持全身麻醉”和“胃肠道内窥镜检查和手术过程中的镇静”。两种申请均基于国内医生主导的临床试验II期和III期研究结果。

Both studies were conducted in adult patients undergoing gastrointestinal endoscopy procedures to assess the efficacy (e.g. success rate of sedation) and safety of the agent. In both studies, the administration of the drug was found to provide adequate sedation regardless of the endoscopy/procedure site and demonstrated a favourable safety profile.Tilmann Bur, CEO of PAION AG, commented: 'Congratulations to our valued partner, Mundipharma, on the remarkable progress achieved in advancing remimazolam in Japan.

两项研究均在接受胃肠道内窥镜检查程序的成年患者中进行，以评估药物的功效（例如镇静成功率）和安全性。在这两项研究中，无论内窥镜检查/手术部位如何，都发现药物的给药提供了足够的镇静作用，并表现出良好的安全性。PAION AG首席执行官Tilmann Bur评论道：“祝贺我们有价值的合作伙伴Mundipharma在推进日本瑞米唑仑方面取得的显着进展。

Together, we are making significant strides in addressing unmet medical needs and improving patient care. We look forward to a future filled with continued success and innovation in healthcare.'Remimazolam (Anerem® 50 mg) for intravenous injection was first approved in Japan in January 2020 for the indi.

总之，我们在解决未满足的医疗需求和改善患者护理方面取得了重大进展。我们期待着充满医疗保健持续成功和创新的未来用于静脉注射的Remimazolam（Anerem®50mg）于2020年1月在日本首次获得indi批准。